- Insmed Incorporated (San Diego, CA)
- …Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV ... Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based ... MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both within… more
- ValSource, Inc. (Durham, NC)
- …and sterilization validation of manufacturing equipment. Experience with cleaning validation , process and utility systems validation , laboratory ... Validation Specialist / Validation Engineer /... (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected to include but… more
- Cipla (Hauppauge, NY)
- …to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and ... working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY… more
- Insmed Incorporated (NJ)
- …(GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation , Quality Management Systems ProcessesWho You Are:Bachelor's ... or San Diego location. The Sr. Quality Engineer, Digital Systems Quality Assurance (QA), is responsible for providing quality...with FDA, ICH, and EU regulations.Review and approve computer system validation (CSV) deliverables (eg, URS, FS,… more
- ValSource, Inc. (Rahway, NJ)
- … validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and ... qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee… more
- Insmed Incorporated (NJ)
- …will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs ... day-to-day operations of the CSV function including managing CSV system folders in the CSV SharePoint site, managing CSV...Experience and Education): 5+ years' experience in a management validation role with responsibility for computer systems … more
- Aequor (San Diego, CA)
- …Summary:Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems .Serve as the CSV ... Acadia on procedures relating to quality, data integrity and computer system validation .Primary Responsibilities:Responsible for supporting the Computerized … more
- Merck & Co. (Rahway, NJ)
- …and device product development, such as manufacturing process development and validation , design control, risk management, material and molding, design validation ... input(s).Lead establishment of test methodologies, including method development and validation , internally or externally, per design verification strategy.Lead strategy… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders ... clinical data programming, reporting, data visualizations, external data acquisition and validation , and tools to support project portfolio across drug programs.… more
- Insmed Incorporated (NJ)
- …operational support like change controls, release management, and reviews of validated systems . Author CSV Documents ( Validation Plans and Summary Reports) ... CSV documents in Veeva Train, coach, and mentor GxP system owners. Who You Are: Position Requirements (Required and/or...and Education): 3+ years' hands on experience in a validation role with responsibility for computer systems … more
- Insmed Incorporated (NJ)
- …leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech, or… more
- ValSource, Inc. (Worcester, MA)
- …within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these environments. Responsibilities include, but ... with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management… more
- Eisai, Inc (Baltimore, MD)
- …in development of Work Plan Templates/Measurement Data TemplatesOversee Blue Mountain System UpgradesDrafts Validation Protocol and Final ReportsExecute ... OOTs are thoroughly investigated and documented. Develops and evaluates quality and system standards within the department to ensure reliability and compliance with… more
- Merck & Co. (Durham, NC)
- …(eg washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)-Automated Systems (eg Distributed Control System (DCS), Programmable Logic ... Controllers (PLC), robotics, Building Automation System (BAS))-Clean-In-Place (CIP) Systems -Maintenance Equipment (eg tools and calibration equipment)-Support to… more
- Merck & Co. (Durham, NC)
- …washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic ... Controllers (PLC), robotics, Building Automation System (BAS))-Clean-In-Place (CIP) Systems -Maintenance Equipment (eg tools and calibration equipment)-Support to… more
- Cipla (Fall River, MA)
- …IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC. SAP Skills in Production, WH, Packaging and Quality ... and vendors / partners. This role will perform IT Systems Support including Systems Implementation, Validation...end business processes to have the capability to propose system changes, process transformations in line with the evolving… more
- Cipla (Reid, WI)
- …of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory ... mitigate impact. Reviews document for accuracy and completeness. Defends the validation programs and strategies to customers and regulatory auditors. Performs weekly… more
- Merck & Co. (Durham, NC)
- …Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation . Position Description: Durham-Technology consists of the Automation/MES, ... Deviation Management, Manufacturing Technical Operations, Validation , and New Product Technical Transfer Departments.The Associate Specialist - Process Engineer will… more
